Fortilink-C 65-C-1012-11-6L

GUDID 00846468080327

FORTILINK-C Tetrafuse 10x12 11mm, 6L

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis
Primary Device ID00846468080327
NIH Device Record Key7449d06e-5570-49b5-bf67-08e539b8fadb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortilink-C
Version Model Number65-C-1012-11-6L
Catalog Number65-C-1012-11-6L
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100846468080327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-05-26

On-Brand Devices [Fortilink-C]

00846468080464FORTILINK-C Tetrafuse 14.5x17 11mm, 6L
00846468080457FORTILINK-C Tetrafuse 14.5x17 10mm, 6L
00846468080440FORTILINK-C Tetrafuse 14.5x17 9mm, 6L
00846468080433FORTILINK-C Tetrafuse 14.5x17 8mm, 6L
00846468080426FORTILINK-C Tetrafuse 14.5x17 7mm, 6L
00846468080419FORTILINK-C Tetrafuse 14.5x17 6mm, 6L
00846468080402FORTILINK-C Tetrafuse 14.5x17 5mm, 6L
00846468080396FORTILINK-C Tetrafuse 12x14 11mm, 6L
00846468080389FORTILINK-C Tetrafuse 12x14 10mm, 6L
00846468080372FORTILINK-C Tetrafuse 12x14 9mm, 6L
00846468080365FORTILINK-C Tetrafuse 12x14 8mm, 6L
00846468080358FORTILINK-C Tetrafuse 12x14 7mm, 6L
00846468080341FORTILINK-C Tetrafuse 12x14 6mm, 6L
00846468080334FORTILINK-C Tetrafuse 12x14 5mm, 6L
00846468080327FORTILINK-C Tetrafuse 10x12 11mm, 6L
00846468080310FORTILINK-C Tetrafuse 10x12 10mm, 6L
00846468080303FORTILINK-C Tetrafuse 10x12 9mm, 6L
00846468080297FORTILINK-C Tetrafuse 10x12 8mm, 6L
00846468080280FORTILINK-C Tetrafuse 10x12 7mm, 6L
00846468080273FORTILINK-C Tetrafuse 10x12 6mm, 6L
00846468080266Fortilink-C Slaphammer
00846468080259Fortilink-C Inserter Housing w/Slaphammer
00846468080242Fortilink-C Tamp, Large
00846468080235Fortilink-C Tamp, Small
00846468080228Fortilink-C Inserter Housing
00846468080211Fortilink-C Case
00846468080204FORTILINK-C Tetrafuse 10x12 5mm, 6L
00846468080198Fortilink-C Inserter Fork Large
00846468080181Fortilink-C Inserter Fork Small

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